Biktarvy is a brand-name prescription medication that’s used to treat HIV-1. It’s a complete treatment for HIV, meaning that you don’t need to take any other HIV drugs with it.

Biktarvy is approved for use in adults and children weighing at least 14 kilograms (kg) (about 31 pounds [lb]), who:

  • haven’t taken antiretrovirals (drugs to treat HIV) before, or
  • are replacing their current antiretroviral treatment and:
    • have no history of treatment failure (which occurs when drugs stop working to control the virus)
    • haven’t had to change treatments in the past because the virus had become resistant to any of the active drugs in Biktarvy

See the “Biktarvy uses” section below for more information about how Biktarvy is used.

Drug details

Biktarvy contains three active drugs from two different antiretroviral drug classes. (A class of drugs is a group of medications that work in a similar way.) These drugs work together to lower the levels of HIV in your body. Specifically, Biktarvy contains:

Biktarvy comes as tablets that are taken once per day. It’s available in two strengths:

  • 50 milligrams (mg) of bictegravir/200 mg of emtricitabine/25 mg of tenofovir alafenamide
  • 30 mg of bictegravir/120 mg of emtricitabine/15 mg of tenofovir alafenamide

FDA approval

Biktarvy was first approved for treating HIV in 2018. It’s the first available HIV drug that contains bictegravir sodium.

Effectiveness

For information about the effectiveness of Biktarvy, see the “Biktarvy uses” section below.

Biktarvy is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Biktarvy can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Biktarvy. But these lists do not include all the possible side effects.

For more information about the potential side effects of Biktarvy, talk with your doctor or pharmacist. They can give you tips about how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Biktarvy, you can do so through MedWatch.

Mild side effects

Mild side effects* of Biktarvy can include:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects of Biktarvy. To learn about other mild side effects, talk with your doctor or pharmacist, or view Biktarvy’s Important Facts.

Serious side effects

Serious side effects of Biktarvy aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Immune reconstitution syndrome, a condition in which your immune system gets stronger with HIV treatment and starts reacting to preexisting infections that may still be in your body. Symptoms vary depending on the type of infection that develops. They may be:
    • “unmasking” symptoms, which are caused by a flare-up of a previously undiagnosed infection soon after starting HIV treatment, or
    • “paradoxical” symptoms, which are caused by a worsening of a previously treated infection after HIV treatment begins
  • New or worsening kidney problems, such as kidney failure. Symptoms can include:
    • urinating less than usual
    • nausea and vomiting
    • shortness of breath
    • itchy skin
    • swollen ankles and feet
    • confusion
  • Liver damage. Symptoms can include:
    • passing urine that’s darker than usual
    • passing stools that are paler than usual
    • nausea
    • abdominal pain
    • loss of appetite
    • jaundice (yellowing of your skin or the whites of your eyes)
  • Lactic acidosis (increased level of lactic acid in your blood). Symptoms can include:
    • weakness
    • fatigue
    • muscle pain
    • shortness of breath or fast breathing
    • fast heart rate
    • nausea and vomiting
    • abdominal pain
    • dizziness
    • hands and feet that are cold or blue
  • Depression and suicidal thoughts or actions.*
  • Allergic reaction.*
  • Worsening hepatitis B after stopping Biktarvy.*†

* For more information about this side effect, see “Side effect details” below.
† Biktarvy has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. See “Side effect details” below for more information.

Side effects in children

Biktarvy is used to treat HIV in children who weigh at least 14 kilograms (kg) (about 31 pounds [lb]), as well as in adults.

Side effects of Biktarvy in children are similar to those reported in adults taking this drug. These side effects are described above and below.

Side effect details

You may wonder how often certain side effects occur with this drug or whether certain side effects pertain to it. Here’s some detail about certain side effects that this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Biktarvy. However, it’s not known how often this may have occurred in clinical studies of the drug.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically involving your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Biktarvy, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Weight gain

Weight gain wasn’t reported in clinical studies of Biktarvy. However, weight gain has been reported in people taking drugs similar to the active drugs in Biktarvy.

For example, weight gain has been reported in people taking certain drugs from a class* called nucleoside reverse transcriptase inhibitors (NRTIs). Weight gain also occurred in people taking certain drugs called integrase inhibitors. Biktarvy contains drugs from both of these classes.†

If you have weight gain while taking Biktarvy, talk with your doctor about ways to manage this.

* A drug class is a group of medications that work in a similar way.
† Biktarvy contains the active drugs emtricitabine and tenofovir alafenamide, which are NRTIs. It also contains the active drug bictegravir sodium, which belongs to a class of drugs called integrase strand transfer inhibitors (INSTIs).

Rash

It’s possible to develop a rash while taking Biktarvy.

In clinical studies, a rash was reported in fewer than 2% of people who took Biktarvy. It’s not known how often a rash may have occurred in people who took other drugs in these studies.

A rash can sometimes be a symptom of an allergic reaction to a drug. (See “Allergic reaction” just above for more details).

If you have a rash while taking Biktarvy, call your doctor right away.

Hair loss

Hair loss wasn’t reported in clinical studies of Biktarvy. However, it has been reported in people taking drugs similar to the active drugs in Biktarvy.

For example, hair loss has occurred in people taking certain drugs from a class* called NRTIs. The study also reported hair loss in people taking certain integrase inhibitors. Biktarvy contains drugs from both of these classes.†

If you have hair loss while taking Biktarvy, talk with your doctor about ways to manage this.

* A drug class is a group of medications that work in a similar way.
† Biktarvy contains the active drugs emtricitabine and tenofovir alafenamide, which are NRTIs. It also contains the active drug bictegravir sodium, which belongs to a class of drugs called INSTIs.

Depression

It’s possible for Biktarvy to cause depression. In some studies, people taking Biktarvy had suicidal thoughts or attempted suicide.

Specifically, in clinical studies, depression occurred in fewer than 2% of people who took Biktarvy. And suicidal thoughts or actions occurred in fewer than 1% of people who took this drug. Most of the people who had suicidal thoughts or actions with Biktarvy had a history of depression, suicide attempts, or mental illness.

It’s not known how often depression or suicidal thoughts or actions may have occurred in people who took other drugs in these studies. And it isn’t known exactly how many deaths due to suicide may have occurred in studies of Biktarvy.

If you have any changes in mood, thoughts, or feelings while taking Biktarvy, call your doctor as soon as possible. If you have thoughts of harming yourself, call 911 or your local emergency number.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

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Worsening of hepatitis B

In people who have hepatitis B and HIV, stopping certain HIV drugs such as Biktarvy can make their hepatitis B worse. In fact, Biktarvy has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA.

Worsening of hepatitis B has been reported in people who stopped taking the drugs emtricitabine, tenofovir disoproxil fumarate, or both. Biktarvy contains emtricitabine and a different form of tenofovir called tenofovir alafenamide. It’s not known how often worsening of hepatitis B may have occurred in clinical studies of Biktarvy, however.

If you have hepatitis B and HIV and you stop taking Biktarvy, your doctor will monitor your liver function for several months. If your hepatitis B gets worse, you may need to take medication to treat it.

As with all medications, the cost of Biktarvy can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Biktarvy. If approved by your insurance company, getting a 90-day supply could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or insurance company.

It’s important to note that you may have to get Biktarvy at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or require help from healthcare professionals to be used safely and effectively.

Before approving coverage for the cost of Biktarvy, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the cost. The insurance company will review the prior authorization request and decide whether to provide coverage.

If you’re not sure whether you’ll need prior authorization for Biktarvy, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Biktarvy or help understanding your insurance coverage, assistance is available.

Gilead Sciences Inc., the manufacturer of Biktarvy, offers a program called Gilead Advancing Access. This provides ways to help lower the cost of the drug. For more information and to find out if you’re eligible, call 800-226-2056 or visit the program’s website.

Mail-order pharmacies

Biktarvy may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If your doctor recommends it, you may be able to receive a 90-day supply of Biktarvy so there’d be less concern about running out of the medication. If you’re interested in this option, check with your doctor and insurance company.

Also, some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, ask your doctor or pharmacist about online pharmacy options.

Generic version

Biktarvy isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

The Food and Drug Administration (FDA) approves prescription drugs, such as Biktarvy, to treat specific conditions.

Biktarvy for HIV

Biktarvy is FDA-approved to treat HIV-1 in adults and children weighing at least 14 kilograms (kg) (about 31 pounds [lb]) who:

  • haven’t taken antiretrovirals (drugs to treat HIV) before, or
  • are replacing their current antiretroviral treatment, and:
    • have no history of treatment failure (which occurs when drugs stop working to control the virus)
    • haven’t had to change treatments in the past because of viral resistance to any of the active drugs in Biktarvy (with viral resistance, the virus develops small changes that make it less sensitive to a particular drug)

HIV is a virus that weakens your immune system. There are two main types of HIV: HIV-1 (the most common type) and HIV-2.

HIV is transmitted through blood, semen, and breast milk, as well as through vaginal and rectal fluids. The virus attacks certain white blood cells called CD4 cells. These cells usually help your immune system fight infections and cancers.

HIV may not cause symptoms for many years. However, if HIV isn’t treated, your CD4 count can fall very low. This can lead to an advanced, life threatening form of HIV called AIDS.

Antiretroviral treatment

HIV is treated with drugs called antiretrovirals. These drugs work to lower your viral load. Antiretrovirals can’t cure HIV, but they can reduce your viral load to a level that’s undetectable with blood tests. The virus is undetectable when there are fewer than 50 copies of HIV per milliliter of blood.

When your viral load is undetectable, the virus can’t transmit to someone else through sex. And there’s a lower risk of the virus transmitting through pregnancy, breastfeeding, or sharing needles. Having an undetectable viral load lowers your risk of infections, as well as the risk of HIV spreading to another person.

Antiretrovirals also allow your CD4 count to increase. This makes your immune system stronger and better equipped to fight infections and cancers. This can help you live a healthier life.

HIV is treated with a combination of drugs that work in different ways against the virus. Biktarvy contains three drugs in one tablet. It’s a complete treatment for HIV-1. This means that you don’t need to take any other HIV drugs with it.

Effectiveness for HIV

Several clinical studies found Biktarvy effective for reducing the HIV viral load to an undetectable level.

Two studies involved adults who hadn’t taken antiretrovirals before. Biktarvy was compared with other, similar triple-drug combinations. In one study, people took either Biktarvy (which contains bictegravir sodium, emtricitabine, and tenofovir alafenamide) or Triumeq (which contains abacavir, dolutegravir and lamivudine). In the other study, people took either Biktarvy or a combination of Tivicay and Descovy. (Tivicay contains dolutegravir. Descovy contains emtricitabine and tenofovir alafenamide.)

After 48 weeks of treatment, the viral load was undetectable in:

  • 89% to 92% of people who took Biktarvy
  • 93% of people who took Triumeq
  • 93% of people who took Tivicay and Descovy

Two other studies involved adults who were currently taking antiretrovirals and had undetectable viral loads. In one study, people taking Triumeq either switched to Biktarvy or kept taking Triumeq. In the other study, people taking a combination of other antiretrovirals either switched to Biktarvy or kept taking their other antiretrovirals.

After 48 weeks of treatment, viral load remained undetectable in:

  • 92% to 94% of people who switched to Biktarvy
  • 95% of people who kept taking Triumeq
  • 89% of people who kept taking a combination of other antiretrovirals

Biktarvy for other conditions

You may wonder if Biktarvy can be used for other conditions. Below we describe one use that Biktarvy should not be prescribed for.

Biktarvy for PrEP (not an appropriate use)

Biktarvy is not FDA-approved for preexposure prophylaxis (PrEP) of HIV. With PrEP, people who don’t have HIV take HIV drugs to reduce their risk of contracting the virus through sex.

Currently, the FDA has only approved three HIV drugs for PrEP. These are Truvada, Descovy, and Apretude. No other drugs are currently recommended for this purpose. It’s not known if other HIV drugs, including Biktarvy, are effective for this use.

If you’d like to know more about PrEP, talk with your doctor.

Biktarvy and children

Biktarvy is FDA-approved to treat HIV in children who weigh at least 14 kilograms (kg) (about 31 pounds [lb]), as well as in adults. It’s not known if Biktarvy is safe or effective for treating HIV in children who weigh less than this amount.

Biktarvy has been studied in children who were currently taking antiretrovirals and had undetectable viral loads. All children in this study stopped their other treatment and switched to Biktarvy. The viral load remained undetectable in:

  • 98% of children ages 12 to 17 years after 48 weeks*
  • 100% of children ages 6 to 11 years after 24 weeks†
  • 91% of children at least 2 years of age after 24 weeks‡

* These children weighed at least 77 pounds (35 kilograms).
† These children weighed at least 55 pounds (25 kilograms).
‡ These children weighed at least 31 pounds (14 kilograms) but less than 55 pounds.

The following information describes Biktarvy dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Biktarvy comes as tablets that you take by mouth. Each tablet contains three active drugs.

It’s available in two strengths:

  • 50 milligrams (mg) of bictegravir/200 mg of emtricitabine/25 mg of tenofovir alafenamide, which is prescribed for adults and children weighing at least 25 kilograms (about 55 pounds).
  • 30 mg of bictegravir/120 mg of emtricitabine/15 mg of tenofovir alafenamide, which is prescribed for children weighing at least 14 kilograms (about 31 pounds) to less than 25 kilograms.

Dosage for HIV

The usual dosage of Biktarvy for HIV is one tablet taken by mouth once a day.

Children’s dosage

Biktarvy can be used to treat HIV in children who weigh at least 14 kilograms (about 31 pounds). The usual dosage for children is one tablet taken by mouth once every day.

What if I miss a dose?

If you miss a dose of Biktarvy, take it as soon as you remember. However, it’s important that you don’t miss doses.

If you miss a dose of Biktarvy, the level of medication in your blood can fall to a point where it no longer controls the virus. This can allow the virus to develop resistance to the medication.

Viral resistance involves the virus developing small changes that make it less sensitive to a particular drug. If this happens with Biktarvy, the medication may become less effective or stop working to control your HIV.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting a daily alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.

Make sure you don’t run out of Biktarvy. Be sure to refill your prescription when your supplies start to run low.

Will I need to use this drug long term?

Yes, Biktarvy is meant to be used as a long-term treatment. If you and your doctor determine that Biktarvy is safe and effective for you, you’ll likely take it long term.

Other drugs that can treat HIV are available. Some may be a better fit for you than others. If you’re interested in finding an alternative to Biktarvy, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of other drugs that may be used to treat HIV include:

  • nucleoside reverse transcriptase inhibitors such as:
    • abacavir (Ziagen)
    • emtricitabine (Emtriva)
    • tenofovir disoproxil fumarate (Viread)
    • zidovudine (Retrovir)
  • non-nucleoside reverse transcriptase inhibitors such as:
    • doravirine (Pifeltro)
    • efavirenz (Sustiva)
    • etravirine (Intelence)
    • nevirapine (Viramune, Viramune XR)
    • rilpivirine (Edurant)
  • protease inhibitors such as:
    • atazanavir (Reyataz)
    • darunavir (Prezista)
    • fosamprenavir (Levixa)
    • ritonavir (Norvir)
    • tipranavir (Aptivus)
  • fusion inhibitors such as:
    • enfuvirtide (Fuzeon)
    • maraviroc (Selzentry)
  • integrase strand transfer inhibitors such as:
    • dolutegravir (Tivicay)
  • attachment inhibitors
    • fostemsavir (Rukobia)
    • ibalizumab-uiyk (Trogarzo)
  • combination drugs such as:
    • abacavir/lamivudine (Epzicom)
    • abacavir/lamivudine/dolutegravir (Triumeq)
    • abacavir/lamivudine/zidovudine (Trizivir)
    • atazanavir/cobicistat (Evotaz)
    • darunavir/cobicistat (Prezcobix)
    • darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza)
    • dolutegravir/lamivudine (Dovato)
    • dolutegravir/rilpivirine (Juluca)
    • doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo)
    • efavirenz/lamivudine/tenofovir disoproxil fumarate (Symfi, Symfi Lo)
    • efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)
    • elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya)
    • elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild)
    • emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey)
    • emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera)
    • emtricitabine/tenofovir alafenamide (Descovy)
    • lamivudine/tenofovir disoproxil fumarate (Cimduo)
    • lamivudine/zidovudine (Combivir)
    • lopinavir/ritonavir (Kaletra)

You may wonder how Biktarvy compares with other medications that are prescribed for similar uses. Here, we look at how Biktarvy and Genvoya are alike and different.

Ingredients

Biktarvy contains three active drugs: bictegravir, emtricitabine, and tenofovir alafenamide.

Genvoya also contains emtricitabine and tenofovir alafenamide. In addition, Genvoya contains elvitegravir and cobicistat.

Uses

Both Biktarvy and Genvoya are approved to treat HIV-1 in adults and certain children who:

  • haven’t taken antiretrovirals (drugs to treat HIV) before, or
  • are replacing their current antiretroviral treatment, and:
    • have no history of treatment failure (which occurs when drugs stop working to control the virus)
    • haven’t had to change treatments in the past because the virus had become resistant to any of the active drugs in Biktarvy or Genvoya

Genvoya can be given to children weighing at least 25 kilograms (about 55 pounds). Biktarvy, on the other hand, can be given to children weighing at least 14 kilograms (about 31 pounds).

Both Biktarvy and Genvoya are complete treatments for HIV. This means that they don’t need to be taken with any other HIV drugs.

Drug forms and administration

Biktarvy and Genvoya both come as tablets that are taken by mouth once every day.

Biktarvy can be taken with or without food. Genvoya should be taken with food.

Side effects and risks

Biktarvy and Genvoya both contain emtricitabine and tenofovir alafenamide. Both medications also contain a type of drug called an integrase inhibitor. Therefore, these medications can cause some similar side effects, but some different ones, as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with either Biktarvy or Genvoya, as well as mild side effects that both drugs may share.

  • Can occur with Biktarvy:
    • abnormal dreams
    • dizziness
    • rash
    • indigestion
  • Can occur with Genvoya:
    • few unique mild side effects
  • Can occur with both Biktarvy and Genvoya:
    • diarrhea
    • nausea
    • headache

Serious side effects

These lists contain examples of serious side effects that can occur with either Biktarvy or Genvoya, as well as serious side effects that both drugs may share.

  • Can occur with Biktarvy:
    • no unique serious side effects
  • Can occur with Genvoya:
    • high cholesterol
  • Can occur with both Biktarvy and Genvoya:
    • immune reconstitution syndrome (a condition in which your immune system gets stronger and starts reacting to germs that may still be in your body from past infections)

* Both Biktarvy and Genvoya have boxed warnings for this side effect. A boxed warning is the most serious warning from the FDA. See “FDA warning: Worsening of hepatitis B” at the beginning of this article for more information.

Effectiveness

The only condition that both Biktarvy and Genvoya are used to treat is HIV.

These drugs haven’t been directly compared in clinical studies, but studies have found both Biktarvy and Genvoya to be effective for treating HIV.

Costs

The price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Biktarvy and Genvoya are both brand-name drugs. There are currently no generic forms of either drug. A generic drug is an exact copy of the active drug in a brand-name medication. Brand-name medications usually cost more than generics.

You may wonder how Biktarvy compares with other medications that are prescribed for similar uses. Here, we look at how Biktarvy and Truvada are alike and different.

Ingredients

Biktarvy contains three active drugs: bictegravir, emtricitabine, and tenofovir alafenamide.

Truvada also contains emtricitabine. In addition, Truvada contains tenofovir disoproxil fumarate.

Tenofovir alafenamide and tenofovir disoproxil fumarate are different forms of the same active drug, tenofovir.*

* The form of tenofovir in Biktarvy is absorbed faster and produces higher levels of tenofovir in the immune cells than the form in Truvada. The form of tenofovir in Biktarvy can also be taken in smaller doses, which lowers the risk of side effects of the drug. (For information about possible side effects of Biktarvy and Truvada, see the “Side effects and risks” section below.)

Uses

Both Biktarvy and Truvada are approved to treat HIV-1 in certain situations.

Biktarvy is a complete treatment for HIV. This means that you don’t need to take other HIV drugs with it. Truvada, however, must be used with other HIV drugs.

Biktarvy is approved for adults and children weighing at least 14 kilograms (about 31 pounds) who:

  • haven’t taken antiretrovirals (drugs to treat HIV) before, or
  • are replacing their current antiretroviral treatment, and:
    • have no history of treatment failure (which occurs when drugs stop working to control the virus)
    • haven’t had to change treatments in the past because the virus had become resistant to any of the active drugs in Biktarvy

Truvada is approved to treat HIV in adults and children weighing at least 17 kilograms (about 37 pounds).

Truvada is also FDA-approved for preexposure prophylaxis (PrEP) of HIV. With PrEP, people who don’t have HIV take HIV drugs to reduce their risk of contracting HIV through sex. Truvada is approved for PrEP in people who weigh at least 35 kilograms (about 77 pounds).

Drug forms and administration

Both Biktarvy and Truvada come as tablets that you take by mouth. Both drugs are taken once every day, with or without food.

Side effects and risks

Biktarvy and Truvada both contain emtricitabine and a form of tenofovir. These medications can cause very similar side effects, but some different ones, as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with either Biktarvy or Truvada, as well as mild side effects that both drugs may share.

  • Can occur with Biktarvy:
    • indigestion
    • gas
  • Can occur with Truvada:
    • upper respiratory infections, such as the common cold
  • Can occur with both Biktarvy and Truvada:
    • diarrhea
    • nausea and vomiting
    • headache
    • abnormal dreams
    • dizziness
    • rash

Serious side effects

These lists contain examples of serious side effects that can occur with either Biktarvy or Truvada, as well as serious side effects that both drugs may share.

  • Can occur with Biktarvy:
    • no unique serious side effects
  • Can occur with Truvada:
    • loss of bone density (which can lead to weakening of bones)
  • Can occur with both Biktarvy and Truvada:
    • immune reconstitution syndrome (a condition in which your immune system gets stronger and starts reacting to germs that may still be in your body from past infections)

* Both Biktarvy and Truvada have boxed warnings for this side effect. A boxed warning is the most serious warning from the FDA. See “FDA warning: Worsening of hepatitis B” at the beginning of this article for more information.

Effectiveness

Biktarvy and Truvada have different FDA-approved uses, but they’re both used to treat HIV.

The use of Biktarvy and Truvada to treat HIV has been directly compared in a clinical study. This study involved adults who were currently taking HIV drugs other than Biktarvy and had undetectable viral loads. (An undetectable viral load means you have a virus level so low that it’s undetectable on lab tests.)

In this study, people either continued taking their current HIV drugs or switched to Biktarvy. For 85% of the people in the study, their current HIV treatment included Truvada, which was taken with two other types of HIV drugs.* After 48 weeks of treatment, the viral load remained undetectable in:

  • 89% of people who kept taking their current HIV drugs
  • 92% of people who switched to Biktarvy

* These drugs included a protease inhibitor (atazanavir or darunavir) and a pharmacokinetic enhancer (cobicistat or ritonavir).

Costs

The price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Biktarvy and Truvada are both brand-name drugs. There’s currently no generic form of Biktarvy. Generic forms of Truvada are available.

Generic drugs are exact copies of the active drugs in a brand-name medication. Brand-name medications usually cost more than generics.

Note: Biktarvy is a complete treatment for HIV, meaning that you don’t need to take any other HIV drugs with it. But Truvada is taken with other HIV drugs. This can affect the total cost of your treatment.

Alcohol isn’t known to affect Biktarvy. However, drinking alcohol with this medication could increase certain side effects of Biktarvy. These side effects include nausea, diarrhea, and headache.

Biktarvy can sometimes cause liver damage, as can regularly drinking large amounts of alcohol. Doing so could raise your risk for liver problems with Biktarvy.

If you drink alcohol, talk with your doctor about how much is safe for you to drink with Biktarvy.

Biktarvy can interact with several other medications. It can also interact with certain herbs and supplements.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Biktarvy and other medications

Below are lists of medications that can interact with Biktarvy. This article does not contain all the drugs that may interact with it.

Before taking Biktarvy, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, or supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Biktarvy and dofetilide

Biktarvy should not be taken with dofetilide (Tikosyn), a drug used to treat irregular heartbeats. Taking Biktarvy with dofetilide can increase the amount of dofetilide in your blood. This can increase your risk for serious side effects of dofetilide.

If you take dofetilide, talk with your doctor about other treatment options.

Biktarvy and certain drugs to treat infections

Taking Biktarvy with certain antimycobacterials, drugs used to treat certain infections, can lower the amount of Biktarvy in your blood. This can make Biktarvy less effective at treating HIV. It can also allow the virus to develop resistance to the drugs in Biktarvy. This can make HIV harder to treat.

Examples of antimycobacterials that can make Biktarvy less effective include:

  • rifampin (Rifadin)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)

Biktarvy should not be taken with rifampin. It’s not usually recommended for use with rifabutin or rifapentine. If you take one of these drugs, talk with your doctor about other treatment options.

Additionally, taking Biktarvy with certain other antibiotics or antivirals used to treat infections can increase your risk for kidney problems. Examples of drugs that increase the risk of kidney problems with Biktarvy include:

If you need to take one of these drugs with Biktarvy, your doctor may monitor your kidney function more closely than usual. Or, they may recommend other treatment options.

Biktarvy and certain seizure medications

Biktarvy is not usually recommended for use with certain seizure medications. This is because taking Biktarvy with these medications can lower the amount of Biktarvy in your blood. And this can make Biktarvy less effective at treating HIV. It can also allow the virus to develop resistance to the drugs in Biktarvy. This can make HIV harder to treat.

Examples of seizure medications that can make Biktarvy less effective include:

If you take one of these drugs, talk with your doctor about other treatment options.

Biktarvy and antacids

Taking Biktarvy with antacids that contain aluminum, calcium, or magnesium can reduce the absorption of Biktarvy into your body. This can make Biktarvy less effective at treating HIV.

Examples of antacids that can make Biktarvy less effective include:

  • aluminum hydroxide/magnesium trisilicate (Gaviscon)
  • aluminum hydroxide/magnesium hydroxide/simethicone (Mylanta maximum strength liquid antacid/anti-gas)
  • calcium carbonate/magnesium hydroxide (Rolaids)
  • calcium carbonate (TUMS)

To avoid this interaction, take Biktarvy at least 2 hours before or 6 hours after you take antacids that contain aluminum or magnesium. For supplements or antacids containing calcium or iron, Biktarvy can be taken at the same time, if it’s taken with food. Talk with your doctor or pharmacist if you have questions about using antacids with Biktarvy.

Biktarvy and nonsteroidal anti-inflammatory drugs, such as ibuprofen

Taking Biktarvy with nonsteroidal anti-inflammatory drugs (NSAIDs) can increase your risk for kidney problems. NSAIDs are drugs that reduce inflammation (swelling) and relieve pain.

Examples of NSAIDs that increase the risk of kidney problems with Biktarvy include:

If you need to take an NSAID with Biktarvy, your doctor may monitor your kidney function more closely than usual. Or, they may recommend alternative treatment options, such as acetaminophen (Tylenol). Acetaminophen is not an NSAID and doesn’t interact with Biktarvy. To read more about this, see the “Common questions about Biktarvy” section below.

Biktarvy and metformin

Taking Biktarvy with metformin (Riomet, Glumetza, Fortamet) may increase the amount of metformin in your blood. This may increase the risk for side effects of metformin, such as low blood sugar or lactic acidosis (increased level of lactic acid in your blood). Biktarvy can also cause lactic acidosis.

If you need to take metformin with Biktarvy, your doctor may monitor your health more closely than usual. Or, they may recommend alternative treatment options.

Biktarvy and herbs and supplements

Below are herbs and supplements that can interact with Biktarvy. This article does not contain all the herbs and supplements that may interact with it.

Check with your doctor or pharmacist before using any herbs or supplements while taking Biktarvy.

Biktarvy and St. John’s wort

Biktarvy should not be taken with the herb St. John’s wort. Taking Biktarvy with St. John’s wort can lower the amount of Biktarvy in your blood. This can make Biktarvy less effective at treating HIV. It can also allow the virus to develop resistance to the drugs in Biktarvy. This can make HIV harder to treat.

Biktarvy and calcium or iron supplements

Taking Biktarvy with calcium or iron supplements can reduce the absorption of Biktarvy into your body. This can make Biktarvy less effective at treating HIV.

If you need to take Biktarvy with a calcium or iron supplement, take both medications at the same time with food. This can help you avoid an interaction.

Biktarvy and foods

There have been no reports of specific foods interacting with Biktarvy. If you have any questions about eating certain foods with Biktarvy, talk with your doctor.

You should take Biktarvy according to your doctor’s or another healthcare professional’s instructions.

When to take

Take Biktarvy once every day. You can take your dose at any time of day. However, you should take your dose around the same time each day.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Biktarvy with food

You can take Biktarvy with or without food.

Can Biktarvy be crushed, split, or chewed?

Biktarvy’s manufacturer hasn’t reported whether Biktarvy tablets can be crushed, split, or chewed for adults and children weighing at least 25 kilograms (about 55 pounds).

For children weighing 14 kilograms (about 31 pounds) to less than 25 kilograms who aren’t able to swallow a whole tablet of Biktarvy, the tablet can be split. However, all tablet pieces must be taken within 10 minutes.

Ideally, Biktarvy should be swallowed whole, if possible. If you have trouble swallowing the pill, talk with your doctor.

Biktarvy is used to treat HIV in certain situations. (See the “Biktarvy uses” section above for details.)

What HIV does in your body

HIV is a virus that weakens your immune system. It invades certain cells in your body called CD4 cells, a type of white blood cell that usually helps your immune system fight infections and cancers.

HIV uses your CD4 cells to make copies of itself. This process is called viral replication. After the virus has replicated, the new copies of the virus are released from the CD4 cells. The CD4 cells then die. The new copies of the virus then infect more CD4 cells, and this process repeats.

If HIV isn’t treated, the viral load (the amount of virus in your body) will continue to increase. Your CD4 count will keep decreasing. Eventually, this can lead to an advanced, life threatening form of the infection, called AIDS.

How HIV is treated

HIV is treated by taking a combination of drugs that work in different ways to stop the virus from replicating. HIV drugs are called antiretrovirals. Taking antiretrovirals every day can reduce your viral load to a level that’s undetectable on lab tests.

How Biktarvy treats HIV

Biktarvy contains three active drugs from two different antiretroviral drug classes. A class is a group of medications that work in a similar way. Biktarvy contains:

The drugs work by blocking the action of certain enzymes that HIV uses to make copies of itself. (An enzyme is a type of protein that helps chemical reactions happen.) Specifically, bictegravir sodium prevents an enzyme called integrase from working. Emtricitabine and tenofovir alafenamide prevent an enzyme called reverse transcriptase from working.

By preventing these enzymes from working, Biktarvy prevents more copies of the virus from being produced. This helps suppress the virus and reduce your viral load.

If your viral load becomes so low that it’s undetectable on lab tests, the virus can’t transmit to someone else through sex. And, there is a lower risk of the virus transmitting through pregnancy, breastfeeding, or sharing needles.

Taking antiretrovirals like Biktarvy also allows your CD4 count to increase. This makes your immune system stronger at fighting infections and cancers, and it can help you live a healthier life.

It’s important to take Biktarvy every day to keep the virus under control. If you miss even a few doses, the amount of medication in your body can become too low to suppress the virus.

For example, emtricitabine has a half-life of about 10 hours. The half-life of a drug is the amount of time it takes for your body to remove half a dose from your system. Emtricitabine could be almost fully removed from your system if you miss just two doses of Biktarvy. This could make Biktarvy less effective. It also increases the risk of HIV becoming resistant to the medication.

How long does it take to work?

Biktarvy starts working against HIV within the first hour after you take a dose.

If you’re switching to Biktarvy from other HIV drugs, Biktarvy will start working right away to keep your viral load undetectable.

If you haven’t taken HIV drugs before, it can take up to 6 months before Biktarvy gets the virus under control.

Here are answers to some frequently asked questions about Biktarvy.

Can your body become resistant to Biktarvy?

No, your body can’t become resistant to Biktarvy. However, it is possible for the HIV in your body to become resistant to Biktarvy.

If HIV becomes resistant to Biktarvy, this makes Biktarvy less effective at treating HIV. As a result, your viral load (the amount of virus in your body) increases.

HIV is more likely to become resistant to Biktarvy if you miss doses of this medication. It’s important that you take Biktarvy every day and don’t miss even a few doses. Be sure to reorder Biktarvy before you run out of the medication.

If HIV becomes resistant to Biktarvy, your doctor will need to change your HIV treatment.

Does Biktarvy interact with Tylenol?

No, Biktarvy doesn’t interact with acetaminophen (Tylenol). If you need to take a pain reliever while you’re taking Biktarvy, it’s usually fine to take Tylenol. However, you should always talk with your doctor or pharmacist before taking any medications with Biktarvy. This includes over-the-counter medications.

Note: Biktarvy may interact with certain nonsteroidal anti-inflammatory drugs, such as ibuprofen. To read more about interactions with Biktarvy, see the “Biktarvy interactions” section above.

Does Biktarvy cause pancreatitis?

It’s not likely. Pancreatitis wasn’t reported in people who took Biktarvy in clinical studies. However, pancreatitis has been reported in people taking drugs similar to the active drugs in Biktarvy.

Specifically, pancreatitis has been reported in people taking certain drugs from a class* called nucleoside reverse transcriptase inhibitors (NRTIs). It’s also occurred in people taking certain integrase inhibitors. Biktarvy contains drugs from both of these classes.†

Symptoms of pancreatitis can include abdominal pain, nausea, vomiting, diarrhea, and loss of appetite. If you have these symptoms while taking Biktarvy, see your doctor.

* A drug class is a group of medications that work in a similar way.
† Biktarvy contains the active drugs emtricitabine and tenofovir alafenamide, which are NRTIs. It also contains the active drug bictegravir sodium, which belongs to a class of drugs called integrase strand transfer inhibitors.

Besides taking Biktarvy, how else can I prevent HIV passing to others?

HIV can pass to others in blood, semen, and breast milk, as well as in vaginal and rectal fluids. You can prevent HIV from passing to others by:

  • using condoms every time you engage in sexual activity
  • choosing sexual activities, such as oral sex, that are less likely to transmit HIV than anal or vaginal sex
  • getting regularly tested and treated for other sexually transmitted infections
  • not sharing needles, syringes, or other drug-injecting equipment with others
  • not breastfeeding

For more information about how to prevent HIV’s transmission, see these recommendations from the Centers for Disease Control and Prevention (CDC).

Does Biktarvy cure HIV?

No, Biktarvy can’t cure HIV. There isn’t currently a cure.

But, taking Biktarvy can suppress the virus in your body. It can even reduce your viral load to levels that are undetectable on lab tests. When your viral load is undetectable, it’s not possible for the virus to pass to others through sex. And, there is a lower risk of HIV transmitting through pregnancy, breastfeeding, or sharing needles. However, this is not the same as a cure.

Keep taking Biktarvy for as long as your doctor prescribes it, even if your viral load is undetectable. If you stop the treatment, this allows your viral load to increase again.

Can older people take Biktarvy?

Biktarvy is likely safe and effective in people ages 65 years and older. However, the drug’s clinical studies didn’t include many older people.

If you’re ages 65 years or older, talk with your doctor about whether Biktarvy could be right for you.

It’s not known if Biktarvy is safe to take during pregnancy. This medication hasn’t been studied in pregnant people.

In animal studies, no harmful effects were seen in a developing fetus when a pregnant animal was given any of the active drugs in Biktarvy. However, animal studies don’t always predict what happens in humans.

Current guidelines recommend that all pregnant females* with HIV take antiretrovirals (drugs to treat HIV). According to the Centers for Disease Control and Prevention (CDC), if you receive HIV treatment early in your pregnancy, the risk of the virus passing to a developing fetus can be 1% or less.

If you have HIV and you’re pregnant or planning to become pregnant, talk with your doctor about your treatment as soon as possible. It’s important to discuss the possible risks and benefits of antiretroviral treatments like Biktarvy. This can help you decide about HIV treatment during your pregnancy.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Pregnancy registry

If you do take Biktarvy during pregnancy, you’re encouraged to sign up for the Antiretroviral Pregnancy Registry. This monitors and records the health of babies born to people who took antiretroviral drugs, such as Biktarvy, while pregnant.

The registry helps healthcare professionals collect information about the safety of drugs like Biktarvy. This can help people make informed decisions about the treatments they take when pregnant.

You can learn more on the registry’s website, and you can enroll by calling 800-258-4263. You can also talk with your doctor about enrolling.

It’s not known if Biktarvy is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Biktarvy.

For more information about taking Biktarvy during pregnancy, see the “Biktarvy and pregnancy” section above.

You should not breastfeed while taking Biktarvy.

Emtricitabine, one of the active drugs in Biktarvy, can pass into breast milk. This could cause side effects in a child who’s breastfed. Taking Biktarvy while breastfeeding could also lead to viral resistance in the breastfed child if they have HIV. Viral resistance involves the virus developing small changes that make it less sensitive to a particular drug.

It’s not known if the other active drugs in Biktarvy pass into breast milk.

Additionally, the Centers for Disease Control and Prevention (CDC) recommends that people living in the United States who have HIV should not breastfeed a child. This is because the virus can pass into breast milk and on to the child. Even if your viral load is undetectable on lab tests while you’re taking Biktarvy, there would still be a risk of HIV passing to a breastfed child.

If you have HIV, talk with your doctor about the best way to feed your child.

This drug comes with several precautions.

FDA warning: Worsening of hepatitis B

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

In people who have hepatitis B and HIV, stopping certain HIV drugs such as Biktarvy can make hepatitis B worse. This has been reported in people who stopped taking the drugs emtricitabine, tenofovir disoproxil fumarate, or both. Biktarvy contains emtricitabine and a different form of tenofovir called tenofovir alafenamide.

If you have hepatitis B and HIV and you stop taking Biktarvy, your doctor will monitor your liver function for several months after you stop the drug. If your hepatitis B gets worse, you may need to take medication to treat it.

See the “Biktarvy side effects” section above for more information.

Other precautions

Before taking Biktarvy, talk with your doctor about your health history. Biktarvy may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Allergic reaction. If you’ve had an allergic reaction to Biktarvy or any of its ingredients, you should not take Biktarvy. Ask your doctor what other medications are better options for you.
  • Liver problems. Your liver is responsible for breaking down two of the active drugs in Biktarvy. If your liver doesn’t work well, these drugs could build up in your body. This could increase your risk of side effects with Biktarvy. Biktarvy can also cause liver damage in some people. Before you start Biktarvy, you’ll have blood tests to check your liver function. You’ll also be tested for hepatitis B, which is an infection of the liver. (See “FDA warning” above for more information). Biktarvy is not recommended for people with severe liver problems. Ask your doctor what other medications may be better options for you.
  • Kidney problems. Tenofovir alafenamide, one of the active drugs in Biktarvy, can cause or worsen kidney problems in some people. If you have kidney problems, talk with your doctor about whether Biktarvy is right for you.
  • History of infections. Biktarvy can cause immune reconstitution syndrome. This is a condition in which your immune system gets stronger and starts reacting to germs that may be hidden in your body from past infections. Examples of these infections include tuberculosis, Pneumocystis jirovecii pneumonia, and cytomegalovirus. If you’ve had one of these infections in the past, you can usually still take Biktarvy. However, you should tell your doctor if you develop any new symptoms after you start the treatment, such as a cough, fever, or fatigue. Your doctor may sometimes prescribe medication to treat these side effects.
  • History of depression or mental illness. Some people have had suicidal thoughts or actions while taking Biktarvy. If you’ve had depression or another mental health condition in the past, talk with your doctor about whether Biktarvy is right for you.
  • Pregnancy. It’s not known if Biktarvy is safe to take during pregnancy. For more information, see the “Biktarvy and pregnancy” section above.
  • Breastfeeding. Biktarvy should not be taken while breastfeeding. For more information, see the “Biktarvy and breastfeeding” section above.

Note: For more information about the potential negative effects of Biktarvy, see the “Biktarvy side effects” section above.

Do not use more Biktarvy than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or an overdose.

What to do in case you take too much Biktarvy

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Biktarvy from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication after the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store it.

Biktarvy tablets should be stored below 86°F (30°C) and away from direct sunlight. Keep the tablets in the bottle they were dispensed in, and keep the bottle tightly closed. Don’t transfer the tablets to another container. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Biktarvy and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips about medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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